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A randomised controlled trial for the effect of preoperative physiotherapy in patients with an increased risk for the development of postoperative pulmonary complications after open-heart surgery.

PreOperative Respiratory physioTherapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29003
Enrollment
600
Registered
2005-09-08
Start date
2002-06-24
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronay artery bypass graft (CABG) surgery

Interventions

The pre-operative physiotherapy consists of a combination of respiratory exercises involving the costo-diaphragm breathing technique, training of the inspiratory muscles for strength and endurance, an

Sponsors

ZonMW (projectnr. 1310.0004)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients who undergo voluntary CABG surgery and have an increased risk of developing a PPC are included in the study. 2. High risk for the development of PPCs is determined by using the risk model (Hulzebos et al.) during the preoperative consultation with the anaesthesiologist (6-8 weeks before the operation) (5). 3. Additional criteria for inclusion in the study are that patients understand Dutch language, and are able to read, are capable of passing a spirometer test and a determination of the mouth pressure, and are prepared to sign a contract of informed consent.

Exclusion criteria

Exclusion criteria: Criteria excluding patients from the experiment include cerebrovascular illnesses; 1. immunosuppressive treatment < 30 days before the operation (chemotherapy or radiotherapy); 2. neuromuscular illnesses (among others Guillein Barré, muscular dystrophy, myasthenia gravis); 3. a previous lung operation; 4. cardiovascular instability; 5. the presence of aneurisms; 6. lung physiotherapy < 8 weeks before the operation; 7. and postoperative cardiac and/or complications involving the central nervous system.

Design outcomes

Primary

MeasureTime frame
Postoperative pulmonary complications (PPCs) are defined as “any pulmonary abnormality occurring in the postoperative period that produces identifiable diseases or dysfunctions that are clinically significant and adversely affect clinical developments” (Brooks-Brunn, 1995). In this study, PPCs are explicitly classified and treated according to the criteria of Kroenke et al. (1992).

Secondary

MeasureTime frame
Length of hospital stay.

Contacts

Public ContactH.J. Hulzebos

University Medical Center Utrecht (UMCU), Huispost STR 5.203, P.O. Box 85500

H.Hulzebos@pmbr.azu.nl+31 (0)30 2538484

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)